Tianjin Empecs Medical Device Co., Ltd.
Manufacturer and brand owner in Tianjin, China. 8 device types, 6 products catalogued, 4 clearances.
Tianjin Empecs Medical Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Glucose Oxidase, Glucose, Glucose Dehydrogenase, Glucose and 6 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.
8device types registered with the FDA
6products catalogued under its own name
4510(k) clearances
Registration
| Registered name | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9616530 |
| FEI number | 3003116995 |
| DUNS | 529128638 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | NO. 35 and 37, YINGCHENG STREET, HANGU |
| Postal code | 300480 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | Class 1 | Smart Diabetes V Blood Glucose Monitoring System, Smart Diabetes V Pro Blood Glucose Monitoring System, Medisign MM3000 Multi Blood Glucose Monitoring System, Medisign MM3000 Blood Glucose Monitoring System | 2014 | 7 |
| Glucose Dehydrogenase, Glucose | Class 2 | Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System and 3 more | 2017 | 5 |
| Glucose Oxidase, Glucose | Class 2 | Smart Diabetes Bluetooth, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System, Medisign MM1000 BT MULTI, MM1100 BT MULTI, MM1200 BT MULTI Blood Glucose Monitoring System, Medisign MM1000 BT, MM1100 BT, MM1200 BT Blood Glucose Monitoring System, Smart Diabetes V Blood Glucose Monitoring System, Smart Diabetes V Pro Blood Glucose Monitoring System, Medisign MM3000 Multi Blood Glucose Monitoring System and 36 more | 2012 | 8 |
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | CX11B1, CareTouch Lancing Device, CareTouch Lancet, Allevy Lancing Device, Allevy Lancet | 2024 | 21 |
| Needle, Acupuncture, Single Use | Class 2 | MAC Ultra Smooth Lancet, MAC Acupuncture Needle, Haeng LIM SEO WON Acupuncture Needl, H.L. SEO WON Acupuncture Needles | 2007 | 33 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | Class 1 | Smart Diabetes Bluetooth, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System, Medisign MM1000 BT MULTI, MM1100 BT MULTI, MM1200 BT MULTI Blood Glucose Monitoring System, Medisign MM1000 BT, MM1100 BT, MM1200 BT Blood Glucose Monitoring System, Smart Diabetes V Blood Glucose Monitoring System, Smart Diabetes V Pro Blood Glucose Monitoring System, Medisign MM3000 Multi Blood Glucose Monitoring System and 36 more | 2012 | 12 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | CX11B1, CareTouch Lancing Device, CareTouch Lancet, Allevy Lancing Device, Allevy Lancet | 2024 | 21 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | Smart Diabetes Bluetooth, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System, Medisign MM1000 BT MULTI, MM1100 BT MULTI, MM1200 BT MULTI Blood Glucose Monitoring System, Medisign MM1000 BT, MM1100 BT, MM1200 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System and 45 more | 2012 | 20 |
Own-Brand Listings
Clearances
4 clearances name Tianjin Empecs Medical Device Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K162564 | 2017-06-07 | NBW | Traditional | This company |
| K152534 | 2017-03-21 | NBW | Special | This company |
| K133260 | 2014-06-27 | NBW | Traditional | This company |
| K111456 | 2012-02-28 | NBW | Traditional | This company |
| K232330 | 2024-01-04 | QRK | Traditional | Ningbo Medsun Medical Co., Ltd. |
| K222246 | 2022-11-21 | QRL | Traditional | Tianjin Rilifine Medical Device Co., Ltd. |
| K220475 | 2022-07-06 | QRL | Traditional | Tianjin Huahong Technology Co., Ltd. |
| K002827 | 2001-02-28 | MQX | Traditional | Haenglim Seowon Medical Co. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Employees | 301-500 |
| Factory area | 5,000-10,000 m² |
| Main products | Blood glucose meters, Blood glucose test strips, Lancets, Acupuncture needles, Moxibustion products |
| Certifications | CE, ISO 13485:2016, FDA, KFDA (Korea), SFDA (China), MFDS (Korea), ANVISA (Brazil) |
| Export markets | North America, Central America, South America, Western Europe, Northern Europe, Southeast Asia, Middle East, Africa, East Asia |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.